Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

452 recalls · Class I, newest first

Class I · High risk

GEC LX Laxoplex 60 capsules Dietary Supplement

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.

Terminated Chemical / undeclared Genetic Edge Compounds LLC D-1092-2017
Class I · High risk

Cummor Natural Male Enhancement

Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin

Terminated Chemical / undeclared Organic Herbal Supply D-0962-2017
Class I · High risk

MACA gold tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0571-2018
Class I · High risk

LIEN CHAN FOR SEVEN DAYS capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0570-2018
Class I · High risk

DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0569-2018
Class I · High risk

Power V8 Viagra tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0568-2018
Class I · High risk

YANSHIJIAONANG capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0567-2018
Class I · High risk

HU HU SHENG WEI capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0566-2018
Class I · High risk

Zhonghua Niubian tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0563-2018
Class I · High risk

ZHANSHENG WEIGE CHAOYUE XILISHI tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0562-2018
Class I · High risk

Clalis capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0560-2018
Class I · High risk

GOLD VIGRA capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0559-2018
Class I · High risk

LANG YI HAO CHAONONGSUOPIAN tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0558-2018
Class I · High risk

GERMANY NIUBIAN tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0556-2018

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